PRUCALOPRIDE SUCCINATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	218812	ANDA	Amneal Pharmaceuticals NY LLC	69238-2698-1	30 TABLET, FILM COATED in 1 BOTTLE (69238-2698-1)	2024-09-30
Amneal	PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	218812	ANDA	Amneal Pharmaceuticals NY LLC	69238-2699-1	30 TABLET, FILM COATED in 1 BOTTLE (69238-2699-1)	2024-09-30
Amneal	PRUCALOPRIDE SUCCINATE	prucalopride succinate	TABLET;ORAL	218812	ANDA	SKG Pharma Inc.	83085-005-30	30 TABLET, FILM COATED in 1 BOTTLE (83085-005-30)	2025-06-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Prucalopride succinate is a highly selective 5-HT4 receptor agonist primarily prescribed for managing chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC). Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), prucalopride has established itself as a vital therapeutic agent in gastrointestinal pharmacology. As demand for this drug grows, sourcing reliable suppliers becomes crucial for pharmaceutical companies, healthcare providers, and distributors aiming for supply chain stability, regulatory compliance, and cost-effectiveness.

This article examines the landscape of suppliers manufacturing prucalopride succinate, their global footprints, manufacturing capacities, regulatory credentials, and market positioning, providing critical insights for stakeholders in the pharmaceutical supply chain.

Market Overview of Prucalopride Succinate

Prucalopride was developed by the pharmaceutical company Shire (now part of Takeda Pharmaceutical Company) and launched in various markets under the brand name Motegrity® in the United States and under different regional brand names elsewhere. The active pharmaceutical ingredient (API), prucalopride succinate, is supplied by multiple manufacturers, including original innovator companies, generic producers, and contract manufacturing organizations (CMOs).

The global demand for prucalopride is driven by a rising prevalence of constipation-related disorders, aging populations, and increasing awareness of minimally invasive gastrointestinal treatments. Ensuring a robust supply chain for prucalopride succinate entails sourcing from reputable producers with proven compliance with international quality standards (e.g., cGMP, ISO).

Key Suppliers of Prucalopride Succinate

1. Original Manufacturer: Takeda Pharmaceutical Company

Takeda holds the patent rights and is the primary producer of the original API used in branded formulations like Motegrity®. They have established manufacturing facilities in Japan and Europe with extensive capacity to meet global demand.

Manufacturing Capabilities: Takeda’s facilities comply with cGMP standards under stringent regulatory oversight, supporting large-volume production in Japan, Europe, and North America.
Regulatory Compliance: Quality assurance aligned with FDA and EMA regulations ensure high-quality API supply.

Note: While Takeda primarily supplies to their internal formulations and licensed partners, their production facilities often serve as the benchmark for quality in the API market.

2. Generics and Contract Manufacturers

As patent exclusivity diminishes or in markets with generic drug regulation, production of prucalopride succinate has expanded beyond Takeda to several generic manufacturers.

a. Zhejiang University of Technology, China

Profile: A prominent player in pharmaceutical intermediates and APIs, Zhejiang University of Technology has developed synthesis routes for prucalopride succinate.
Regulatory Status: Their API manufacturing facility holds ISO 9001 and QS (Quality System) certifications. Chinese API manufactures are increasingly gaining acceptance in global markets following validation audits.

b. Sarabhai Enterprises, India

Profile: Sarabhai is recognized for developing generic versions of various GI drugs. They have scaled up manufacturing capacities for prucalopride succinate using established synthetic pathways.
Quality & Compliance: Their APIs are cGMP-certified, with exports to Europe, North America, and Australia.

c. Dr. Reddy’s Laboratories, India

Profile: Dr. Reddy’s has announced capacity expansion plans for prucalopride succinate to serve the North American and European markets, leveraging their robust CMO network.
Regulatory Status: API supplied by Dr. Reddy’s generally meets global quality standards and undergoes rigorous validation.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource prucalopride succinate synthesis to specialized CMOs with expertise in complex organic synthesis and API manufacturing.

Patheon (Thermo Fisher Scientific): Offers cGMP-compliant production of specialty APIs, including prucalopride succinate, with a global manufacturing footprint.
Novasep: Provides custom synthesis capabilities for prucalopride succinate, promoting scalability and regulatory compliance.
WuXi AppTec: A leading CMO with expertise in gastrointestinal API manufacturing, including complex serotonergic agents.

4. Emerging Suppliers and Market Trends

The growth of the generic API market, especially in Asia, has facilitated new suppliers entering the fray. Countries like South Korea, Singapore, and Taiwan are investing in API manufacturing infrastructure and quality systems, rapidly expanding available options for prucalopride succinate.

Supply Chain Considerations

Regulatory Approval and Validation

For distributors and pharmaceutical companies, supplier validation involves examining:

Certificate of Analysis (CoA): Confirming API purity (>99%), residual solvent levels, and stability.
Regulatory Compliance: Suppliers must adhere to cGMP guidelines and have successful audits by global regulators.
Traceability: Full documentation of batch records from synthesis to delivery.

Manufacturing Capacity and Lead Times

Capacity evaluations should be based on:

Production throughput, batch sizes, and scalability.
Lead times from order placement to API delivery.
Flexibility during supply disruptions, especially considering geopolitical factors and pandemic impacts.

Pricing and Cost Factors

Price competitiveness varies based on:

Production scale.
The extent of quality testing.
Regional manufacturing costs.

Quality Assurance and Validation

Ensuring supplier compliance with international standards reduces risk related to:

Batch variability.
Regulatory rejeсtions.
Market recalls.

Market Dynamics and Future Outlook

Emerging biosimilar and generic manufacturers are entering the prucalopride succinate market, increasing supply options and potentially reducing prices. Further, investments in API process innovation aim to enhance yield, reduce costs, and improve sustainability.

Strategic alliances and licensing agreements between original developers like Takeda and third-party manufacturers are likely to persist, expanding global availability and reducing supply constraints.

Key Takeaways

Major supply of prucalopride succinate originates from Takeda, the original developer, with extensive capacity in Japan and Europe.
A growing number of generic manufacturers, primarily based in China, India, and Southeast Asia, produce high-quality APIs meeting global standards.
Contract manufacturing organizations play a crucial role in scaling production, ensuring regulatory compliance, and maintaining supply stability.
Supply chain risk mitigation requires diligent supplier validation, quality monitoring, and strategic inventory planning.
Market expansion and technological innovations in API synthesis are expected to enhance supply availability and cost efficiency in the coming years.

FAQs

1. Is prucalopride succinate available from multiple suppliers worldwide?
Yes. While Takeda remains the primary producer, numerous generic manufacturers in China and India now supply high-quality prucalopride succinate, expanding global availability.

2. What are the key factors to consider when sourcing prucalopride succinate?
Regulatory compliance, manufacturing capacity, quality assurance, lead times, and cost are essential factors for reliable sourcing.

3. Are APIs from Chinese and Indian manufacturers accepted by Western regulators?
Yes, provided they meet stringent standards such as cGMP and pass regulatory audits. Many have gained approval for producing APIs used in registered medicines.

4. What role do CMOs play in the prucalopride succinate supply chain?
CMOs provide custom synthesis, scale-up manufacturing, and validation services, ensuring supply continuity and quality management.

5. How might market trends impact the availability of prucalopride succinate in the future?
Increased competition, process innovations, and strategic alliances will likely lead to greater supply stability, lower costs, and expanded access globally.

References

FDA Motegrity® (prucalopride) approval documentation
EMA Prucalopride Summary of Product Characteristics
Global API market reports (e.g., IQVIA, EvaluatePharma)
Company websites and regulatory filings for Takeda, Dr. Reddy’s, Sarabhai
Industry publications on API manufacturing and supply chain management

Suppliers and packagers for PRUCALOPRIDE SUCCINATE